Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)

K201390 · Medline Industires, Inc. · LZC · Sep 18, 2020 · General Hospital

Device Facts

• Record ID: K201390
• Device Name: Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
• Applicant: Medline Industires, Inc.
• Product Code: LZC · General Hospital
• Decision Date: Sep 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, ambidextrous, powder-free nitrile examination gloves; intended for medical use to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Gloves provide a barrier against patient fluids and are tested for resistance to permeation by specific chemotherapy drugs per ASTM D6978-05. Output is a physical barrier; healthcare providers use the gloves during patient examinations and chemotherapy drug handling to protect themselves from exposure. Benefits include reduced risk of contamination and chemical exposure.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-10, ISO 10993-05), physical properties (ASTM D6319-10), residual powder (ASTM D6124-06), freedom from holes (ASTM D5151-06), and chemotherapy drug permeation (ASTM D6978-05).

Technological Characteristics

Nitrile material; powder-free; ambidextrous; beaded cuff; light blue color. Complies with ASTM D6319-10 for physical dimensions and properties. Non-sterile. Biocompatibility per ISO 10993-1, 10993-10, 10993-05. Chemotherapy resistance tested per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525)

Submission Summary (Full Text)

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September 18, 2020

Medline Industires, Inc. Adam Ostrower Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K201390

Trade/Device Name: Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: June 24, 2020 Received: June 25, 2020

Dear Adam Ostrower:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201390

Device Name

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy)

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes

Caution: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa WARNING: Do not use with Carmustine

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.

**Medline Industries, Inc.**
Three Lakes Drive
Northfield, IL 60093

# 510(k) SUMMARY (K201390) [AS REQUIRED BY 21CFR807.92(c)]

## Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

## Contact Person

Adam Ostrower Regulatory Affairs Sr. Specialist Phone: [phone] Email: [e-mail]

Summary Preparation Date September 18, 2020

Type of 510(k) Submission Traditional

## Device Name / Classification

Trade Name: Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) Common Name: Patient Examination Glove, Specialty Classification Name: Patient Examination Glove, Specialty Product Code: LZA, LZC Classification Panel: General Hospital Regulatory Class: I Regulation Number: 21 CFR 880.6250

## Predicate Device

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs – K172525

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Image /page/4/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo is set against a blue square background. A white, stylized starburst or cross shape is prominently displayed, with the word "MEDLINE" in bold, white letters positioned horizontally across the center of the shape. A gray bar is visible on the right side of the image.

**Medline Industries, Inc.**
Three Lakes Drive
Northfield, IL 60093

#### Device Description

The Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) are single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, light blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

#### Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| CHEMOTHERAPY DRUG TESTED | | BREAKTHROUGH TIME (IN MINUTES) |
|-------------------------------|-------------------------|--------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 25.3 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | ≥ 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | ≥ 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | ≥ 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | ≥ 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | ≥ 240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | ≥ 240 |
| Methotrexate | 25 mg/ml (25,000 ppm) | ≥ 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | ≥ 240 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | ≥ 240 |
| Thio-Tepa | 10.0 mg/ml (10,000 ppm) | 43.7 |
| Vincristine Sulfate (Oncovin) | 1.0 mg/ml (1,000 ppm) | ≥ 240 |

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes

## CAUTION: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa WARNING: Do not use with Carmustine

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized star shape behind it. The star shape has four points, with the top and bottom points being longer than the side points.

## Summary of Technological Characteristics

### TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

| DEVICE<br>CHARACTERISTICS | PROPOSED DEVICE | PREDICATE DEVICE | COMPARISON<br>ANALYSIS |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Powder-Free Light Blue Nitrile<br>Exam Gloves (Tested for Use<br>with Chemotherapy Drugs) | Blue Non-Sterile Powder Free<br>Nitrile Examination Gloves<br>Tested for Use with<br>Chemotherapy Drugs | Similar |
| 510(k) Reference | K201390 | K172525 | |
| Product Owner | Medline Industries, Inc. | Central Medicare | Different |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Intended Use | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand to<br>prevent contamination<br>between patient and examiner.<br>These gloves were tested for<br>use with chemotherapy drugs<br>as per ASTM D6978-05(2019)<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs. | Blue Non-Sterile Powder Free<br>Nitrile Examination Gloves<br>Tested for Use with<br>Chemotherapy Drugs is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>to prevent contamination<br>between patient and<br>examiner. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Light Blue | Blue | Similar |
| Sizes | Small, Medium, Large, Extra<br>Large | Extra-Small, Small, Medium,<br>Large, Extra Large | Similar |
| Dimensions - Length | Complies with ASTM D6319-10<br>240mm min. | Complies with ASTM D6319-<br>10<br>230mm min. | Different |
| Dimensions - Width | Complies with ASTM D6319-10<br>XS: N/A<br>S: 85±10<br>M: 95±10<br>L: 105±10<br>XL: 115±10 | Complies with ASTM D6319-<br>10<br>XS: 70±10<br>S: 80±10<br>M: 95±10<br>L: 110±10<br>XL: 120±10 | Similar |
| Dimensions -<br>Thickness | Complies with ASTM D6319-10<br>Palm - 0.14<br>Finger - 0.16<br>Cuff - 0.12 | Complies with ASTM D6319-<br>10<br>Palm - 0.06±10<br>Finger - 0.08±10<br>Cuff - 0.10±10 | Different |
| Physical Properties | Complies with ASTM D6319-10<br>minimum:<br>Tensile Strength:<br>Before Aging ≥17 MPa, min<br>After Aging ≥14 MPa, min<br><br>Elongation:<br>Before Aging 500% Min<br>After Aging 400% Min | Tensile Strength:<br>Before Aging ≥15 MPa, min<br>After Aging ≥14 MPa, min<br><br>Elongation:<br>Before Aging 500% Min<br>After Aging 400% Min | Similar |
| Disposable vs. Non-<br>Disposable | Disposable | Disposable | Same |
| Freedom from Holes | Complies with ASTM D6319-10<br>and ASTM D5151-06 G-1, AQL<br>2.5 | In accordance with ASTM<br>D5151-06, following ASTM<br>D6319 AQL 2.5/Inspection<br>Level G-1 | Same |
| Powder or Powder-<br>Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Max. 0.52mg per glove | Max. 0.52mg per glove | Same |
| Contact Duration | Limited 24 hours | Limited 24 hours | Same |
| Biocompatibility | AAMI/ANSI/ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>Cytotoxic<br>Non-Toxic | Not a skin irritant<br>Not a skin sensitizer | |
| Sterility | Non-Sterile | Non-Sterile | Same |
| | Carmustine (BCNU) 3.3 mg/ml:<br>25.3 Minutes | Carmustine (3.3 mg/ml): 12.4<br>Minutes | Different |
| | Cisplatin 1.0 mg/ml: ≥240<br>Minutes | Cisplatin (1.0 mg/ml): ≥240<br>Minutes | Same |
| | Cyclophosphamide (Cytoxan)<br>20.0 mg/ml: ≥240 Minutes | Cyclophosphamide (20<br>mg/ml) : ≥240 Minutes | Same |
| | Dacarbazine (DTIC) 10.0 mg/ml:<br>≥240 Minutes | Dacarbazine (10.0 mg/ml):<br>≥240 Minutes | Same |
| Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough<br>Detection Time as<br>Tested per ASTM D<br>6978 | Doxorubicin Hydrochloride 2.0<br>mg/ml: ≥240 Minutes | Doxorubicin HCI (2.0 mg/ml):<br>≥240 Minutes | Same |
| | Etoposide (Toposar) 20.0<br>mg/ml: ≥240 Minutes | Etoposide (20.0 mg/ml): ≥240<br>Minutes | Same |
| | Fluorouracil 50.0 mg/ml: ≥240<br>Minutes | Fluorouracil (50.0 mh/ml):<br>≥240 Minutes | Same |
| | Methotrexate 25 mg/ml: ≥240<br>Minutes | Not Tested | Different |
| | Mitomycin C 0.5 mg/ml: ≥ 240<br>Minutes | Not Tested | Different |
| | Not Tested | Mixotantrone (2.0 mg/ml):<br>≥240 Minutes | Different |
| | Paclitaxel (Taxol) 6.0 mg/ml:<br>≥240 Minutes | Paclitaxel (6.0 mg/ml): ≥240<br>Minutes | Same |
| Thio-Tepa 10.0 mg/ml: 43.7<br>Minutes | Thiotepa (10.0 mg/ml): 24.4<br>Minutes | Different | |
| Vincristine Sulfate (Oncovin) 1.0<br>mg/ml: ≥240 Minutes | Vincristine Sulfate (1.0<br>mg/ml): ≥240 Minutes | Same | |

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Image /page/6/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The symbol is composed of four pointed shapes converging at a central point. A small portion of a gray rectangle is visible on the right edge of the image.

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.

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Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, placed on the left side of the image. To the right of the word is a white, stylized starburst shape. The background is a solid dark blue color.

#### Summary of Non-Clinical Testing

The biocompatibility evaluation for Medline Powder-Free Light Blue (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation within a Risk Management Process, as recognized by FDA.

The following tests were performed to evaluate the biocompatibility of the Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs):

- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- ISO 10993-05: Cytotoxicity

#### Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.

In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

- ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D 6124-06 (Reapproved 2011) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D 6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

#### Summary of Clinical Testing

No clinical study is included in this submission.

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Image /page/9/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized white symbol that resembles a compass or a star. The symbol has four points, with the top and bottom points being longer than the side points. A small gray rectangle is visible in the upper right corner of the image.

#### Conclusion

In accordance with 21 CFR Part 807, and based on the nonclinical information provided in this premarket notification Medline Industries, Inc. concludes that Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better for its intended use as the legally marketed predicate device, Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, K172525.